FDA Says Amphetamine Sulfate Not Withdrawn for Safety, Effectiveness

Amphetamine sulfate 5 mg and 10 mg tablets were not withdrawn from sale for reasons of safety or effectiveness, the Food and Drug Administration said in a Nov. 10 Federal Register notice (75 Fed. Reg. 69088).

The notice said this determination means that the agency will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) for generics that refer to these strengths of amphetamine sulfate and will continue to approve ANDAs that refer to this drug.

Accordingly, the agency will continue to list the drug in the “Discontinued Drug Product List” section of the ...